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多层面策略以终结开普敦年轻夫妇中的 HIV:一项整群随机试验的研究方案。

Multilevel strategies to end HIV for young couples in Cape Town: Study protocol for a cluster randomized trial.

机构信息

RTI International, Research Triangle Park, Durham, NC, United States of America.

Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.

出版信息

PLoS One. 2024 Jun 7;19(6):e0305056. doi: 10.1371/journal.pone.0305056. eCollection 2024.

Abstract

This protocol presents a multilevel cluster randomized study in 24 communities in Cape Town, South Africa. The study comprises four specific aims. Aim 1, conducted during the formative phase, was to modify the original Couples Health CoOp (CHC) intervention to include antiretroviral therapy/pre-exposure prophylaxis (ART/PrEP), called the Couples Health CoOp Plus (CHC+), with review from our Community Collaborative Board and a Peer Advisory Board. Aim 1 has been completed for staging the trial. Aim 2 is to evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and people in their community seeking HIV services (testing/ART/PrEP) and other health services in their local clinics. Aim 3 is to test the efficacy of the CHC+ to increase both partners' PrEP/ART initiation and adherence (at 3 and 6 months) and to reduce alcohol and other drug use, sexual risk and gender-based violence, and to enhance positive gender norms and communication relative to HIV testing services (n = 480 couples). Aim 4 seeks to examine through mixed methods the interaction of the stigma awareness workshop and the CHC+ on increased PrEP and ART initiation, retention, and adherence among young women and their primary partners. Ongoing collaborations with community peer leaders and local outreach staff from these communities are essential for reaching the project's aims. Additionally, a manualized field protocol with regular training, fidelity checks, and quality assurance are critical components of this multilevel community trial for successful ongoing data collection. Trial registration. Clinicaltrials.gov Registration Number: NCT05310773. Pan African Trials: pactr.samrc.ac.za/ Registration Number: PACTR202205640398485.

摘要

本方案介绍了在南非开普敦的 24 个社区中进行的一项多层次集群随机研究。该研究包含四个具体目标。目标 1 在形成阶段进行,旨在对原始的夫妇健康合作社(CHC)干预措施进行修改,纳入抗逆转录病毒治疗/暴露前预防(ART/PrEP),称为夫妇健康合作社加(CHC+),并经我们的社区合作委员会和同行咨询委员会审查。目标 1 已完成试验分期。目标 2 是评估一个关于污名意识和教育研讨会对社区成员对使用 AOD 的年轻男女和他们所在社区中寻求 HIV 服务(检测/ART/PrEP)以及其他健康服务的态度和行为的影响,并在他们当地的诊所。目标 3 是测试 CHC+的功效,以增加双方的 PrEP/ART 开始和坚持率(在 3 个月和 6 个月时),并减少酒精和其他药物使用、性风险和基于性别的暴力,以及增强与 HIV 检测服务相关的积极性别规范和沟通(n = 480 对夫妇)。目标 4 旨在通过混合方法研究污名意识研讨会和 CHC+对增加年轻女性及其主要伴侣的 PrEP 和 ART 起始、保留和坚持的相互作用。与来自这些社区的社区同伴领袖和当地外展工作人员的持续合作对于实现项目目标至关重要。此外,一个带有定期培训、保真度检查和质量保证的手册化现场方案是这一多层面社区试验成功进行持续数据收集的关键组成部分。试验注册。Clinicaltrials.gov 注册号:NCT05310773。泛非试验:pactr.samrc.ac.za/ 注册号:PACTR202205640398485。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64f7/11161046/5d07b73f304a/pone.0305056.g001.jpg

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